Device product
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Z-2076-2021
Product summary
- Event
- Event 88089
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21,685
- Official record key
device-enforcement:Z-2076-2021
Official wording
Reason: Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
Code information: Model Number: LNQ22
Distribution pattern: Worldwide distribution - US Nationwide in the states of AK, AL, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. The countries of Australia, Austria, Canada, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Netherlands Antilles, Sweden, Switzerland, and United Kingdom.
Derived failure modes
-
Unknown
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.